Clinical Trials /

A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

NCT01975701

Description:

This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to adult patients with histologically confirmed GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.

Related Conditions:
  • Glioma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

A Phase 2 Study of <span class="go-doc-concept go-doc-intervention">BGJ398</span> in Patients With Recurrent GBM

Title

  • Brief Title: A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
  • Official Title: A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma
  • Clinical Trial IDs

    NCT ID: NCT01975701

    ORG ID: CBGJ398X2201

    Trial Conditions

    Recurrent Glioblastoma or Other Glioma Subtypes

    Trial Interventions

    Drug Synonyms Arms
    BGJ398 BGJ398X

    Trial Purpose

    This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to
    adult patients with histologically confirmed GBM and/or other glioma subtypes with
    FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.

    Detailed Description

    Patients will be enrolled in two groups. Group 1 will enroll patients who are not candidates
    for surgery. Group 2 will enroll patients who are surgical candidates. Patients from both
    groups will be evaluated for tumor response and progression by MRI every 8 weeks until
    disease progression or discontinuation from study using RANO criteria.

    Trial Arms

    Name Type Description Interventions
    BGJ398X Experimental To estimate anti-tumor efficacy of BGJ398 BGJ398

    Eligibility Criteria

    Inclusion criteria:

    1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time
    of diagnosis or prior relapse.

    2. Written documentation of local or central laboratory determination of amplification
    or translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mutation in
    FGFR1, FGFR2,or FGFR3

    3. RANO defined tumor progression by MRI in comparison to a prior scan

    4. Patients must have received prior external beam radiotherapy and temozolomide.

    Exclusion criteria:

    1. History of another primary malignancy

    2. Prior or current treatment with a FGFR inhibitor

    3. Neurological symptoms related to underlying disease requiring increasing doses of
    corticosteroids

    4. Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If
    previously on an EIAED, the patient must be off of it for at least two weeks prior to
    study treatment.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    progression free survival

    Secondary Outcome Measures

    Overall response rate

    Overall survival

    safety and tolerability

    Trial Keywords

    BGJ398,

    recurrent glioblastoma'

    recurrent GBM,

    FGFR,